The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes

Inclusion Criteria

Patients must have:

• AIDS.
• CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
• Intolerance or resistance to other therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Eligibility to participate in a controlled clinical trial of ISIS 2922.
• External ocular infection in eye to be treated.
• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.
• Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.
• Retinal detachment in eye to be treated.
• Known or suspected allergy to phosphorothioate oligonucleotides.
• Silicone oil in eye to be treated.
• Syphilis.
• Clinical evidence of retinal pigment epithelial stippling.
• Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

• Foscarnet.
• Mellaril, Stelazine, Thorazine, and Clofazimine.
• Ethambutol / fluconazole combination.
• Other investigational drugs for CMV retinitis.

Patients with the following prior conditions are excluded:

• History of surgery to correct retinal detachment in eye to be treated.
• History of ganciclovir implant for treatment of CMV retinitis.
• History of intolerance to ISIS 2922.
• History of syphilis.

Required:

• Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.